A Study in Healthy Volunteers

Hepatitis B Clinical Trial

Official title:

A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596697
• Other study ID #: CTRV-CRV431-101
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2019
• Est. completion date: June 4, 2021

Study information

• Verified date: November 2021
• Source: Hepion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 4, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Capable of giving written informed consent
• Willing and able to complete all study requirements
• Healthy male or female between 18 and 55 years of age (inclusive);
• Body mass index 16 to 32 kg/m2 (inclusive);

Exclusion Criteria:

• Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
• Current or history of abuse of alcohol or illicit drugs
• Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug.

Additional Exclusion Criteria for HBV Pilot Subjects Only:

• Evidence of significant liver fibrosis or cirrhosis
• History of NAFLD or NASH
• Positive test for HDV

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis B
• Infections
• Infectious Disease
• Liver Diseases

Intervention

Drug:
• CRV431
Single or multiple dose(s) of CRV431
• Placebo
Single Placebo dose
• TDF
Single or multiple dose(s) of TDF

Locations

Country	Name	City	State
United States	Celerion, Inc	Lincoln	Nebraska
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	Celerion, Inc	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Hepion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events		56 days